Urea 39% Cream 227gm
It is used to treat some skin problems. It is used to treat some nail problems.
Drug Class
Keratolytic; Emollient
Pharmacologic Class
Humectant; Keratolytic Agent
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Urea cream is used to soften and moisturize rough, dry, or scaly skin conditions like eczema, psoriasis, corns, calluses, and cracked heels. It helps the skin shed dead cells and hold more moisture, making it smoother and softer.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Wash your hands thoroughly before and after applying the medication, unless your hand is the area being treated. If your hand is the treated area, do not wash it after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Only apply the medication to the affected area.
If necessary, the treated area may be covered with a bandage or dressing.
Storage and Disposal
Store this medication at room temperature, away from heat sources.
Do not freeze the medication.
Keep the container tightly closed when not in use.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Wash your hands thoroughly before and after applying the medication, unless your hand is the area being treated. If your hand is the treated area, do not wash it after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Only apply the medication to the affected area.
If necessary, the treated area may be covered with a bandage or dressing.
Storage and Disposal
Store this medication at room temperature, away from heat sources.
Do not freeze the medication.
Keep the container tightly closed when not in use.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply to clean, dry skin.
- Wash hands before and after application.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Do not apply to open wounds, broken, or severely inflamed skin unless directed by a healthcare professional.
- For external use only.
- Regular, consistent application is key for best results.
Available Forms & Alternatives
Available Strengths:
- Urea Hydrating 35% Foam
- Urea 45% Cream 255gm
- Urea Nail 45% Gel 28ml
- Urea 39% Cream 226.8gm
- Urea 20% Cream 85gm
- Urea 40% Cream 28.35gm
- Urea 40% Cream 85gm
- Urea 40% Cream 198.4gm
- Urea 41% Cream 227gm
- Urea 47% Cream 142gm
- Urea 40% Lotion 226.8gm
- Urea 39% Cream 227gm
- Urea 10% Hydrating Cream 85gm
- Urea 10% Lotion 177ml
- Urea 10% Lotion 240ml
- Urea 10% Cream 85gm
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected skin areas 1 to 3 times daily, or as directed by a physician.
Condition-Specific Dosing:
hyperkeratosis:
Apply to affected areas after cleansing and drying, gently massage until absorbed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established, consult pediatrician
Child:
Apply to affected skin areas 1 to 3 times daily, or as directed by a physician. Use with caution on large areas or broken skin.
Adolescent:
Apply to affected skin areas 1 to 3 times daily, or as directed by a physician.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Urea is a keratolytic agent that softens the horny layer of the skin, promoting desquamation and increasing the water-binding capacity of the stratum corneum. It acts as a humectant, drawing moisture into the skin, and also has mild proteolytic activity, helping to dissolve the intercellular matrix of the stratum corneum, leading to shedding of scales and softening of hyperkeratotic areas.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemically (primarily local action)
Tmax:
Not applicable for systemic effect
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable systemically
ProteinBinding:
Not applicable systemically
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable systemically
Clearance:
Not applicable systemically
ExcretionRoute:
Not applicable systemically
Unchanged:
Not applicable systemically
Pharmacodynamics
OnsetOfAction:
Days to weeks for noticeable softening and reduction of hyperkeratosis.
PeakEffect:
Not well-defined for topical effect; continuous application maintains effect.
DurationOfAction:
Depends on continued application and severity of condition.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Burning or stinging
- Itching
- Irritation at the site where the drug was applied
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Burning or stinging
- Itching
- Irritation at the site where the drug was applied
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe burning, stinging, or irritation that does not subside.
- Signs of allergic reaction such as rash, hives, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
- Worsening of skin condition.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of use, and do not exceed the recommended treatment period.
If ingested, this medication can be harmful. In the event of accidental ingestion, immediately contact a doctor or a poison control center for assistance.
To minimize potential risks, avoid applying this medication to irritated skin, open wounds, or infected skin areas. Using this medication too frequently can exacerbate your skin condition.
Before using other medications or skin products, including soaps, consult with your doctor to ensure safe and effective treatment.
If you are pregnant, planning to become pregnant, or are breast-feeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision about its use.
If ingested, this medication can be harmful. In the event of accidental ingestion, immediately contact a doctor or a poison control center for assistance.
To minimize potential risks, avoid applying this medication to irritated skin, open wounds, or infected skin areas. Using this medication too frequently can exacerbate your skin condition.
Before using other medications or skin products, including soaps, consult with your doctor to ensure safe and effective treatment.
If you are pregnant, planning to become pregnant, or are breast-feeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision about its use.
Overdose Information
Overdose Symptoms:
- Systemic overdose is highly unlikely with topical application due to minimal absorption.
- Excessive topical application may lead to increased local irritation (e.g., redness, burning, peeling).
What to Do:
Discontinue use. Wash affected area with soap and water. If irritation persists, seek medical attention. For accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or emergency services.
Drug Interactions
Minor Interactions
- Other topical agents (may increase irritation or absorption of other drugs if applied concurrently to the same area, especially on broken skin).
Monitoring
Baseline Monitoring
Skin assessment (e.g., dryness, scaling, thickness, presence of fissures)
Rationale: To establish baseline severity of dermatological condition.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin condition (e.g., hydration, softness, reduction in scaling)
Frequency: Weekly to monthly, or as clinically indicated.
Target: Improvement in skin texture and appearance.
Action Threshold: Lack of improvement or worsening of condition may require re-evaluation of therapy.
Local irritation (e.g., redness, burning, stinging, itching)
Frequency: Daily, especially during initial use.
Target: Absence or minimal transient irritation.
Action Threshold: Persistent or severe irritation warrants discontinuation and medical consultation.
Symptom Monitoring
- Increased redness
- Burning sensation
- Stinging
- Itching
- Peeling beyond expected desquamation
- Swelling
- Signs of allergic reaction (e.g., rash, hives)
Special Patient Groups
Pregnancy
Urea topical is generally considered safe for use during pregnancy. Systemic absorption is minimal, limiting fetal exposure.
Trimester-Specific Risks:
First Trimester:
Low risk; minimal systemic absorption.
Second Trimester:
Low risk; minimal systemic absorption.
Third Trimester:
Low risk; minimal systemic absorption.
Lactation
Urea topical is generally considered safe for use during lactation. Minimal systemic absorption means negligible excretion into breast milk. Avoid applying to areas where the infant may ingest the cream.
Infant Risk:
Low risk.
Pediatric Use
Generally safe for children, but use with caution on large surface areas or broken skin, especially in very young children, due to potential for increased absorption. Consult a pediatrician for use in infants and young children.
Geriatric Use
No specific dose adjustments are necessary. Use with caution on very fragile or thin skin, as irritation may be more pronounced.
Clinical Information
Clinical Pearls
- Urea creams are highly effective for conditions characterized by dry, rough, or thickened skin, such as xerosis, ichthyosis, psoriasis, and hyperkeratotic eczema.
- Higher concentrations (e.g., 30-40%) are typically used for more severe hyperkeratotic conditions like corns, calluses, and nail dystrophies, while lower concentrations (e.g., 5-20%) are used for general moisturization and mild dryness.
- Patients should be advised that a mild stinging or burning sensation may occur, especially on initial application or if applied to broken skin. This is usually transient.
- Occlusion (e.g., covering with plastic wrap or socks) can enhance penetration and efficacy for very thick lesions, but should only be done under medical supervision due to increased risk of irritation.
- Consistent, daily application is crucial for achieving and maintaining therapeutic benefits.
Alternative Therapies
- Salicylic acid (keratolytic)
- Lactic acid (alpha hydroxy acid, humectant/keratolytic)
- Ammonium lactate (humectant/keratolytic)
- Emollients (e.g., petrolatum, mineral oil, dimethicone)
- Corticosteroids (for inflammatory skin conditions)
- Calcipotriene (for psoriasis)
Cost & Coverage
Average Cost:
Price varies widely (typically $20-$60) per 227gm tube/jar
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often OTC or covered with prescription)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.